A phase II study to evaluate the safety and efficacy of topical 3% amphotericin B cream (Anfoleish) for the treatment of uncomplicated cutaneous leishmaniasis in Colombia

by López L, Vélez I, Asela C, Cruz C, Alves F, Robledo S, Arana BPLoS Neglected Tropical Diseases 2018, 2(7): e0006653. doi: 10.1371/journal.pntd.0006653.

Summary: Better therapeutic options are needed for the treatment of cutaneous leishmaniasis (CL). Anfoleish, a topical formulation based on 3% Amphotericin B and developed by HUMAX and PECET, has been shown to be safe and efficacious in animal models and in an open label study in CL patients. The authors present the results of the first controlled and randomized study assessing the safety and efficacy of Anfoleish administered topically, two or three times per day for 28 days, for the treatment of non-complicated CL in Colombia. Although Anfoleish was safe and well-tolerated, its efficacy results do not support continuing its clinical development or recommending it for the treatment of CL. Additional studies to improve its current formulation are needed.

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